Emerging innovations in clinical trial design

Designs of clinical trials have changed little since the advent of randomization in the 1940s. Modern innovations in designs are being driven by the increasing recognition in clinical research that diseases are heterogeneous and patients who apparently have the same disease require different therapi...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 99; no. 1; p. 82
Main Author Berry, D A
Format Journal Article
LanguageEnglish
Published United States 01.01.2016
Subjects
Clinical Trials as Topic - methods
Humans
Medical Oncology - methods
Research Design
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Summary:Designs of clinical trials have changed little since the advent of randomization in the 1940s. Modern innovations in designs are being driven by the increasing recognition in clinical research that diseases are heterogeneous and patients who apparently have the same disease require different therapies. This article describes some innovations in clinical trial design across therapeutic areas but with a focus on oncology. No one knows what the future holds for clinical trial design but the status quo of large trials that pretend the patient population is homogeneous is not sustainable, either economically or scientifically/medically. No one knows what the eventual business model and regulatory model will be, but they will be very different from today's.
ISSN:1532-6535
DOI:10.1002/cpt.285